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When Is An Abuse-Deterrent Claim FDA Approved?

 
• By Sue Sutter

Agency says it is seeing confusion in the marketplace when it comes to distinguishing between agency-approved labeling claims and advertising about products that are intended to be abuse deterrent.

FDA draws a bright line between abuse-deterrent claims that satisfy its 2015 guidance document and those that do not, but the distinction is not always clear to those outside the agency.

The potential for confusion about what is and is not an abuse-deterrent opioid product under the guidance was evident at the advisory committee review of Teva Pharmaceutical Industries Ltd.'s...

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LDT Final Act? US FDA Will Not Appeal District Court Decision Vacating Final Rule

 
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Novo, Lilly Ad Challenges Cause Discontinued Claims For Compounded GLP-1s

 
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Prasad Says Involvement In US FDA Product Approvals Will Mirror Prior CBER Directors

 
• By Sarah Karlin-Smith

The remarks from the new CBER director suggest Prasad will not be involved in most product-specific decisions.

More from North America

Scientists Work With AI To Uncover ‘Unexpected’ Drug Combos For Breast Cancer

 
• By Natasha Barrow

A UK research team has used artificial intelligence to find new treatments for cancer using existing US Food and Drug Administration-approved medicines that are not normally not used for the disease.

Saving Part D: US Medicare Advisors Sound The Alarm

 
• By Michael McCaughan

The US Medicare Payment Advisory Commission worries that Medicare prescription drug market trends may cause the stand-alone plan portion of the program to “wither away,” which could take the traditional fee-for-service side of Medicare with it.

Clinical Trials Nonprofit Fights for Access Despite DEI Crack-Down

 
• By Sue Sutter

The Clinical Trials Access Collaborative (CTAC) will build on a pilot program's work to bolster community-based clinical research infrastructure so "anyone who wants to participate in clinical trials can and do it closer to home,” CEO Tesheia Harris said in an interview.